Pascale van Hoydonck can count on a 22+ years professional career, first academic research (PhD) and later in business development both in clinical affairs and regulatory affairs. She has become a trusted collaborator to internal and external stakeholders in several aspects of management of Phase I clinical trials (Pharma, MSD) and providing insightful knowledge in European legislation through participating in international medical device working groups (IMDRF WG on software, MDCG WG and Regulatory Affairs Committee at MedTech Europe. As Director Regulatory Affairs EMEA (Terumo BCT), she was part of the R&D department and developing the regulatory strategies for new medical devices in different medical domains.

With her pragmatic regulatory insight, she is working since 2021 as Senior QA/RA consultant (Qualix) supporting MedTech Organizations to bring their innovative products (such as Artificial Intelligence, active devices, implants, IVDS, ...) on the market. This QA/RA service includes but are not limited to, defining the regulatory strategy, setting up quality management system, supporting clinical study application and clinical evaluation, regulatory technical file writing, and being the primary liaison with international regulators and Notified bodies for certification of products. In this role, she ahs a strong collaboration with R&D teams, clinical departments, and manufacturing teams. In addition, Pascale has supported EU notified body with aligning the QMS for designation under IVDR and she has provided lectures on the new European (inVitro Diagnostic) Medical Device Regulation to the universities, research organisations and Health Institutions.